Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to define the safety of using bioimpedance for analysis of body composition in heart failure patients with ICD devices. The Biospace America InBody 520 scale, using direct segmental multifrequency bioimpedance, will be utilized to assess patients' fat mass, lean muscle mass, and edema status. Although the Biospace America InBody 520 scale is routinely used to analyze body composition in various settings including the Ahmanson-UCLA Cardiomyopathy clinic, due to theoretical concerns of safety, bioimpedance has not been routinely used in patients with ICDs. The investigators hope that this study will allow us to routinely analyze body composition in heart failure patients with ICDs, information which can be used to help guide dietary, exercise, and medical prescriptions for the investigators heart failure patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jan 2011
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 15, 2011
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedResults Posted
Study results publicly available
March 10, 2020
CompletedMarch 10, 2020
March 1, 2020
2 months
August 15, 2011
April 1, 2019
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Arrhythmia as Detected by ICD
Subjects with HF and ICD had their ICD interrogated and continually monitored by an electrophysiologist before, during, and after 30-50 seconds of bioimpedance analysis, which involves standing on the InBody 520 scale. Outcome measure was assessed during a one day visit. There is no further follow-up.
1 day, on day of study ICD interrogated and continually monitored before, during, and after 30-50 seconds of bioimpedance analysis
Study Arms (1)
Body Composition Analysis InBody Scale
EXPERIMENTALInterventions
Patients will have their ICD interrogated using a pacemaker Programmer specifically designed from one of the 4 pacemaker manufacturers: St. Jude, Medtronic, Guidant, and Biotronik. Depending on the type of pacemaker, interrogation can be done either wirelessly or by placing a wand over the pacemaker. The ICD will be turned to a "monitor-only" mode to disable risk of ICD shock by the supervising electrophysiologist. Patient will be asked to step on the InBody 520 scale to have their body composition analyzed. Patient will continue to have their ICD actively monitored. Analysis will take approximately 30 - 50 seconds. At the end of analysis, ICD device will be returned to default settings by supervising electrophysiologist.
Eligibility Criteria
You may qualify if:
- HF patients of any etiology who currently have an implanted ICD
You may not qualify if:
- patients who are non-ambulatory
- have a physical disability making them unable to stand on the InBody
- those who are above the height and weight maximums for the device \[Height \> 220cm (7'2.6''), Weight \> 250kg (551lb)\]
- those who are pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahmanson-UCLA Cardiomyopathy Center
Los Angeles, California, 90095, United States
Related Publications (1)
Buch E, Bradfield J, Larson T, Horwich T. Effect of bioimpedance body composition analysis on function of implanted cardiac devices. Pacing Clin Electrophysiol. 2012 Jun;35(6):681-4. doi: 10.1111/j.1540-8159.2012.03377.x. Epub 2012 Mar 27.
PMID: 22452409RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to small sample, we cannot exclude rare BIA-ICD interactions. Results may not be generalizable to other devices or BIA systems that utilize different frequencies.
Results Point of Contact
- Title
- Tamara Horwich, MD, MS
- Organization
- Ahmanson-UCLA Cardiomyopathy Center
Study Officials
- PRINCIPAL INVESTIGATOR
Tamara Horwich, MD, MS
University of California, Los Angeles
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Tamara Horwich, M.D., M.S.
Study Record Dates
First Submitted
August 15, 2011
First Posted
April 2, 2012
Study Start
January 1, 2011
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
March 10, 2020
Results First Posted
March 10, 2020
Record last verified: 2020-03